Venom 0406860125Recalls & reported problems
Stryker Corporation · RF Cannula, CVD · Class 2
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 07613327118605), received between May 26, 2021 and Oct 15, 2025 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Biocompatibility” (1 report).
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.
Reports received per month
Most reported problems
Device problems
- Biocompatibility1
- Unintended Power Up1
Patient problems
- Local Reaction1
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionOct 15, 2025Unintended Power Up; Unintended Power Up
IT WAS REPORTED THAT PRIOR A PROCEDURE THE E-SEP SAFEAIR PENCIL WAS FOUND TO BE FAULT. IT WAS ACTIVATING ON ITS OWN. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT A DELAY; NO ADVERSE CONSEQUENCES OR INJURY WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23300825 ↗MalfunctionMay 26, 2021Biocompatibility; Biocompatibility
IT WAS REPORTED THAT A COUPLE OF DAYS FOLLOWING AN RF ABLATION PROCEDURE THE PATIENT PRESENTED WITH PAIN AT THE SITE OF ABLATION DURING A TELEMEDICINE APPOINTMENT. UPON REFERRAL TO A DERMATOLOGIST AN ALLERGIC REACTION WAS DIAGNOSED AND SILVER SULFADIAZINE CREAM WAS PRESCRIBED. THE SITE HAS CONTINUED TO HEAL AND NO FURTHER ADVERSE CONSEQUENCES HAVE BEEN REPORTED.
Patient problems: Local Reaction
MAUDE report 11886308 ↗
Other PROBE, RADIOFREQUENCY LESION devices
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- NA TCN-10-3MBoston Scientific Neuromodulation Corporation · PROBE, RADIOFREQUENCY LESION2 recalls9 reports
- NA CSK-TC10Boston Scientific Neuromodulation Corporation · PROBE, RADIOFREQUENCY LESION1 recall1 death58 reports
- NA CLASSICSt. Jude Medical, Inc. · PROBE, RADIOFREQUENCY LESION1 recall40 reports
- Intracept RLV 0055Relievant Medsystems, Inc. · Probe, Radiofrequency Lesion1 recall30 reports
- Intracept RLV 0045Relievant Medsystems, Inc. · Probe, Radiofrequency Lesion1 recall1 death23 reports
- Intracept RLV0065Relievant Medsystems, Inc. · Probe, Radiofrequency Lesion1 recall14 reports
- NA CSK-TC5Boston Scientific Neuromodulation Corporation · PROBE, RADIOFREQUENCY LESION1 recall3 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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